Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Oximeter
510(k) Number K082268
Device Name CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX
Applicant
Oridion Capnography, Inc.
Har Hotzvim Science Park
Pob 45025
Jerusalem,  IL 91450
Applicant Contact RACHEL WEISSBROD
Correspondent
Oridion Capnography, Inc.
Har Hotzvim Science Park
Pob 45025
Jerusalem,  IL 91450
Correspondent Contact RACHEL WEISSBROD
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
CCK  
Date Received08/11/2008
Decision Date 02/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT00659516
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-